Integra cranial access kit recalled for sterile packaging failure
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall for packaging integrity failure resulting in potential sterility compromise. No illnesses or injuries reported; the hazard is preventive rather than confirmed.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,324 units of the Integra Cranial Access Kit (Ref No: INS5HND) worldwide due to a defect in the sterile packaging of the product.
The header bag packaging failed required integrity testing criteria, which means the sterility of the device may be compromised. These kits are designed for neurosurgical access to the subarachnoid space or lateral ventricles of the brain.
The affected products have been distributed in the United States and 17 other countries including Canada, France, Germany, Spain, United Kingdom, and others. Affected lot numbers include 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, and 7300837, with expiration dates ranging from June 29, 2025 to July 29, 2025.
Healthcare facilities should stop using affected units and contact Integra LifeSciences for return or replacement instructions.
The recalled product
- Product
- Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurosurgical
- Affected units
- 1,324
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighIntegra Cranial Access Kit Recalled for Defective Outer Packaging
FDA (Devices) · 2023-12-13
- HighCranial Access Kit Recall Due to Packaging Defect Compromising Sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit packaging defect compromises device sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit Packaging Defect Compromises Sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit recalled due to packaging defect
FDA (Devices) · 2023-12-13